Regulatory Relationship Manager II
TD
Regulatory Affairs Specialist
Medline Industries, LP
full-time
Posted on:
Location Type: Remote
Location: Remote • Illinois, Montana, North Carolina, South Dakota, Vermont • 🇺🇸 United States
Visit company websiteSalary
💰 $79,560 - $115,440 per year
Job Level
JuniorMid-Level
About the role
- Plan and execute global regulatory activities necessary to obtain and maintain global regulatory approvals
- Prepare comprehensive regulatory strategies for new devices, new launch markets, and post-market device changes
- Ensure content, context, organization, and quality of supporting information meets regulatory requirements
- Determine requirements for completing and maintaining product submissions and regulatory filings for assigned market(s)
- Communicate requirements of regulations to internal or external customers and recommend regulatory pathways and strategies
- Review and provide feedback on documentation and supporting evidence to ensure regulatory compliance
- Complete and maintain regulatory filings by collaborating with internal and external groups and evaluating technical information
- Write appropriate summary documentation and support responses to non-conformances and questions from regulators
- Participate in development, review, and substantiation of product labeling and claims
- Present project objectives, solve problems, and act as a regulatory resource and subject matter expert
Requirements
- B.A. or B.S. degree in life science field (biology, microbiology, chemistry, etc.), engineering, medical technology, regulatory science, or related
- 2 years of experience in medical device regulatory affairs or quality assurance
- Understanding of the current Regulatory environment
- Applied knowledge of FDA regulations and guidelines
- Ability to evaluate information to determine compliance with standards, laws, and regulations
- Ability to review complex regulatory issues and apply specialized experience
- Travel required up to 5%
Benefits
- competitive total rewards package
- continuing education & training
- bonus and/or incentive eligible
- health insurance
- life and disability insurance
- 401(k) contributions
- paid time off
- Employee Assistance Program (for roles <30 hours includes access)
- Employee Resource Groups
- Employee Service Corp
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
regulatory strategyregulatory complianceregulatory filingsproduct submissionsdocumentation reviewlabeling and claims substantiationproblem-solvingtechnical evaluationFDA regulationsquality assurance
Soft skills
communicationcollaborationorganizational skillsattention to detailanalytical skillsinterpersonal skillssubject matter expertiseproject managementcritical thinkingcustomer service
